(115 days)
Not Found
Not Found
No
The description details a molecular assay based on nucleic acid detection and microarray technology, with results determined by light scatter intensity. There is no mention of AI or ML algorithms being used for data analysis or decision-making.
No.
The device is an in vitro diagnostic test used to detect and identify bacterial species and a resistance marker to aid in the diagnosis of bloodstream infections; it does not provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is a "qualitative, multiplexed in vitro diagnostic test" to "aid in the diagnosis of bacterial bloodstream infections."
No
The device is a system that includes both hardware (Verigene Reader and Verigene Processor SP) and software components for performing a molecular assay. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states it is a "qualitative, multiplexed in vitro diagnostic test". It also describes its use for detecting and identifying pathogens and resistance markers in blood culture samples, which are performed outside the body (in vitro) to aid in diagnosis.
- Device Description: The description details a system that processes biological samples (blood culture) to detect specific nucleic acid targets, which is a hallmark of in vitro diagnostic devices.
- Performance Studies: The document includes detailed descriptions of analytical and clinical performance studies, including method comparison with reference methods, sensitivity, specificity, and precision. These types of studies are required for the regulatory approval of IVD devices.
N/A
Intended Use / Indications for Use
The Verigene® Staphylococcus Blood Culture (BC-S) Nucleic Acid Test performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacterial species Staphylococcus aureus ("SA") and Staphylococcus epidermidis ("SE") which may cause bloodstream infection (BSI). In addition, the BC-S test detects the mecA resistance marker inferring mecA-mediated methicillin/oxacillin resistance. In mixed growth, the BC-S Test does not specifically attribute mecA-mediated methicillin/oxacillin resistance to either SA or SE.
The BC-S test is performed directly on positive blood culture using BACTEC™ Plus Aerobic/F and BacT/ALERT FA FAN® Aerobic blood culture bottles, which contain gram-positive cocci in clusters (GPCCL) observed on Gram stain. Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing, differentiation of mixed growth, association of the mecA gene to an organism, or for epidemiological typing.
The BC-S test is indicated for use in conjunction with other clinical and laboratory findings, such as culture, to aid in the diagnosis of bacterial bloodstream infections; however, it is not used to monitor bloodstream infections.
Product codes (comma separated list FDA assigned to the subject device)
NQX, NSU
Device Description
The Verigene Staphylococcus Blood Culture Nucleic Acid Test (BC-S) is a molecular assay which relies on detection of specific nucleic acid targets in a microarray format. For each of the bacterial nucleic acid sequences detected by the BC-S test, Capture and Mediator oligonucleotides are utilized for gold nanoparticle probe-based endpoint detection. The Capture oligonucleotides bind to a specific portion of the nucleic acid target and are themselves bound onto a substrate in the microarray. The Mediator oligonucleotides bind to a different portion of the same nucleic acid target and allow binding of a gold nanoparticle probe to a portion complementary to a gold nanoparticle probe. Specific silver enhancement of the bound gold nanoparticle probes at the capture sites results in gold-silver aggregates that scatter light with high efficiency.
The BC-S test is performed on the Verigene System, a 'sample-to-result', fully automated, bench-top molecular diagnostics workstation. The Verigene System consists of two components: the Verigene Reader and the Verigene Processor SP. The BC-S test utilizes single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested. For the BC-S test, the Verigene System allows automated nucleic acid extraction from gram-positive bacteria-containing blood culture specimens and target detection of bacteria-specific DNA.
The Reader is the Verigene System's user interface, which serves as the central control unit for all aspects of test processing and results generation. The Reader's graphical user interface guides the user through test processing and test results using a barcode scanner.
The user inserts the Test Cartridge into the Verigene Processor SP, which executes the test procedure, automating the steps of ( ) Sample Preparation - Cell lysis and magnetic bead-based bacterial DNA isolation from blood culture samples and (2) Verigene Hybridization Test - Detection and identification of bacterial-specific DNA in a microarray format by using gold nanoparticle probe-based technology.
After test processing is complete, to obtain the test results the user removes the Test Cartridge from the Processor SP, removes the reagent pack from the substrate holder, and inserts the substrate holder into the Reader for analysis. Light scatter from the capture spots is imaged by the Reader and intensities from the microarray spots are used to make decisions regarding the presence (Detected) or absence (Not Detected) of a bacterial nucleic acid sequence/analyte.
Mentions image processing
Light scatter from the capture spots is imaged by the Reader and intensities from the microarray spots are used to make decisions regarding the presence (Detected) or absence (Not Detected) of a bacterial nucleic acid sequence/analyte.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bloodstream
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical Sensitivity / Limit of Detection (LOD): Analytical sensitivity (LODs) for detection of 13 strains tested ranged from 1.9 x 10^8 to 7.5 x 10^6 CFU/mL.
Analytical Reactivity (Inclusivity): Demonstrated reactivity to strains included 99 MRSA strains (including 65 representative NARSA strains), 18 methicillin-sensitive Staphylococcus aureus (SA), eight (8) borderline oxacillin-resistant Staphylococcus aureus or BORSA strains, six (6) methicillin-resistant Staphylococcus epidermidis (MRSE), and seven (7) methicillinsensitive Staphylococcus epidermidis (SE).
Analytical Specificity (Exclusivity): No cross-reactivity observed for any of the strains tested, which included 157 bacterial (115 gram-positive and 40 gram-negative, 1 acid-fast positive and 1 mollicute) and 6 yeast strains.
Interfering Substances: No inhibitory effects observed from interfering substances including hemoglobin, triglycerides, bilirubin, gamma-globulin, and SPS, introduced directly into blood and then cultured in the blood culture bottle. Multiple types of blood culture bottles were also tested.
Fresh vs. Frozen Samples: Test results for representative strains of MRSA/SA and MRSE/SE were unaffected by exposure to up to two freeze/thaw cycles.
Competitive Inhibition: Competitive inhibition representing mixed bacteremia with SA and SE was evaluated by testing SA/MRSA samples at a high titer in the presence of SE/MRSE at a low titer (at LOD) and vice versa. No evidence of competitive inhibition was observed.
Carry-over / Cross-contamination: No evidence of carryover and/or cross-contamination from the high positive samples, or any other internal or external sources, was observed during either the sample extraction and hybridization procedural steps, when alternately running high positive samples followed by true negative samples.
Precision and Reproducibility Studies:
Study Type: Reproducibility Study (external at three sites) and Precision Study (internal at Nanosphere, Inc.).
Sample Size: The Precision and Reproducibility Study Panel comprised of twelve (12) specimens, consisting of pure isolates grown in blood culture bottles until bottle positivity and bottle positivity plus an additional 8 hours. The specimens included 2 levels of 2 different MRSA strains, 2 levels of a MRSE strain. 2 negative controls (1 media only and 1 bacterial), 2 levels of an SA strain, and 2 levels of an SE strain. Each specimen was tested in duplicate twice daily by two operators for twelve days (precision) and five days (reproducibility).
Key Results: The study demonstrated excellent reproducibility across multiple reagent lots, days, operators, runs, instruments and replicates.
Precision: 100 % (576/576) 99.4 % - 100 %
Reproducibility Site 1: 100 % (240/240) 98.5 % - 100 %
Reproducibility Site 2: 100 % (240/240) 98.5 % - 100 %
Reproducibility Site 3: 100 % (240/240) 98.5 % - 100 %
Reproducibility All Sites: 100 % (1296 / 1296) 99.7 % - 100 %
Method Comparison:
Study Type: Method Comparison Study
Sample Size: Three-hundred and thirty (330) culture-positive, gram-positive (GPCCL) blood culture specimens.
Key Results: BC-S test results were compared with reference method results obtained from the standard biochemical bacterial detection and susceptibility techniques utilized in routine clinical practice.
S. aureus (n=330): Sensitivity =100% (97.1%-100%), Specificity=100% (98.2%-100%).
S. epidermidis (n=330): Sensitivity = 97.0% (91.2%-99.4%), Specificity= 99.6% (97.6%-99.9%).
mecA (n=221): Sensitivity =98.6% (94.6%-99.8%), Specificity= 98.8% (93.4%-99.9%).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity =100% (97.1%-100%) for S. aureus
Specificity=100% (98.2%-100%) for S. aureus
Sensitivity = 97.0% (91.2%-99.4%) for S. epidermidis
Specificity= 99.6% (97.6%-99.9%) for S. epidermidis
Sensitivity =98.6% (94.6%-99.8%) for mecA
Specificity= 98.8% (93.4%-99.9%) for mecA
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.1640 Antimicrobial susceptibility test powder.
(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).
0
PAGE UPDATED December 13, 2011
5. 510(K) Summary
The Summary for this 510(k) submission is submitted in accordance with the requirements of SMDA 1900 and CFR 807.92. Attachment A contains the 510(k) screening checklist and Attachment B contains the complete 510(k) Summary.
510(k) Number:
Verigene® Staphylococcus Blood Culture Nucleic Acid Test (BC-S) K112424
Summary Preparation Date:
August 19, 2011 (Revised December 13, 2011)
Submitted by:
Nanosphere, Inc. 4088 Commercial Avenue Northbrook, IL 60062 Phone: 847-400-9000 Fax: 847-400-9199
Contact:
Mark Del Vecchio VP, Regulatory Affairs and Quality Assurance
Proprietary Names:
For the instrument:
Verigene® System
For the assay:
Verigene® Staphylococcus Blood Culture Nucleic Acid Test (BC-S)
2 \REGULATORY\Submissions\BSI\BC-S\Final Oct 13 RFAI Response\'S 3C S Test 510(k) 08192011 FINAL_formatted_revised 12132011.docx
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PAGE UPDATED December 13, 2011
Common Names:
For the instrument:
Bench-top molecular diagnostics workstation
For the assay:
Rapid gram-positive blood culture assay Staphylococcus aureus-Staphylococcus epidermidis blood culture assay Methicillin-resistant Staphylococcus aureus (MRSA) blood culture assay Methicillin-resistant Staphylococcus epidermidis (MRSE) blood culture assay
Regulatory Information:
Regulation section:
866.1640 Antimicrobial susceptibility powder
Classification:
Class II
Panel:
Microbiology (83)
Product Code(s):
NQX System, nucleic acid amplification test, DNA, methicillin-resistant Staphylococcus aureus, direct specimen
Other:
Instrumentation for clinical multiplex test systems NSU
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Page 28 of 168
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PAGE UPDATED December 13, 2011
Predicate Devices:
Xpert MRSA/SA Blood Culture Assay (Cepheid)
S. aureus/CNS PNA FISH Culture Identification Kit (AdvanDx)
Phoenix Gram Positive (GP) Panel - Phoenix Automated Microbiology System (Cefoxitin) (Becton-Dickinson)
Verigene RVNAT5P Test (Nanosphere)
Indications for Use:
The Verigene® Staphylococcus Blood Culture (BC-S) Nucleic Acid Test performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacterial species Staphylococcus aureus ("SA") and Staphylococcus epidermidis ("SE") which may cause bloodstream infection (BSI). In addition, the BC-S test detects the mecA resistance marker inferring mecA-mediated methicillin/oxacillin resistance. In mixed growth, the BC-S Test does not specifically attribute mecA-mediated methicillin/oxacillin resistance to either SA or SE.
The BC-S test is performed directly on positive blood culture using BACTEC™ Plus Aerobic/F and BacT/ALERT FA FAN® Aerobic blood culture bottles, which contain gram-positive cocci in clusters (GPCCL) observed on Gram stain. Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing, differentiation of mixed growth, association of the mecA gene to an organism, or for epidemiological typing.
The BC-S test is indicated for use in conjunction with other clinical and laboratory findings, such as culture, to aid in the diagnosis of bacterial bloodstream infections; however, it is not used to monitor bloodstream infections.
Technological Characteristics:
The Verigene Staphylococcus Blood Culture Nucleic Acid Test (BC-S) is a molecular assay which relies on detection of specific nucleic acid targets in a microarray format. For each of the bacterial nucleic acid sequences detected by the BC-S test, Capture and Mediator oligonucleotides are utilized for gold nanoparticle probe-based endpoint detection. The Capture oligonucleotides bind to a specific portion of the nucleic acid target and are themselves bound onto a substrate in the microarray. The Mediator oligonucleotides bind to a different portion of the same nucleic acid target and allow binding of a gold nanoparticle probe to a portion complementary to a gold nanoparticle probe. Specific silver enhancement of the bound gold nanoparticle probes at the capture sites results in gold-silver aggregates that scatter light with high efficiency.
CONFIDENTIAL AND PROPRIETARY Nanosphere, Inc.
Page 29 of 168
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PAGE UPDATED December 13, 2011
The BC-S test is performed on the Verigene System, a 'sample-to-result', fully automated, bench-top molecular diagnostics workstation. The Verigene System consists of two components: the Verigene Reader and the Verigene Processor SP. The BC-S test utilizes single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested. For the BC-S test, the Verigene System allows automated nucleic acid extraction from gram-positive bacteria-containing blood culture specimens and target detection of bacteria-specific DNA.
The Reader is the Verigene System's user interface, which serves as the central control unit for all aspects of test processing and results generation. The Reader's graphical user interface guides the user through test processing and test results using a barcode scanner.
The user inserts the Test Cartridge into the Verigene Processor SP, which executes the test procedure, automating the steps of ( ) Sample Preparation - Cell lysis and magnetic bead-based bacterial DNA isolation from blood culture samples and (2) Verigene Hybridization Test - Detection and identification of bacterial-specific DNA in a microarray format by using gold nanoparticle probe-based technology.
After test processing is complete, to obtain the test results the user removes the Test Cartridge from the Processor SP, removes the reagent pack from the substrate holder, and inserts the substrate holder into the Reader for analysis. Light scatter from the capture spots is imaged by the Reader and intensities from the microarray spots are used to make decisions regarding the presence (Detected) or absence (Not Detected) of a bacterial nucleic acid sequence/analyte.
Performance Data - Analytical Testing
Analytical Sensitivity / Limit of Detection (LOD)
Analytical sensitivity (LODs) for detection of 13 strains tested ranged from 1.9 x 108 to 7.5 x 106 CFU/mL.
Analytical Reactivity (Inclusivity)
Demonstrated reactivity to strains included 99 MRSA strains (including 65 representative NARSA strains), 18 methicillin-sensitive Staphylococcus aureus (SA), eight (8) borderline oxacillin-resistant Staphylococcus aureus or BORSA strains, six (6) methicillin-resistant Staphylococcus epidermidis (MRSE), and seven (7) methicillinsensitive Staphylococcus epidermidis (SE).
Analytical Specificity (Exclusivity)
No cross-reactivity observed for any of the strains tested, which included 157 bacterial (115 gram-positive and 40 gram-negative, 1 acid-fast positive and 1 mollicute) and 6 yeast strains.
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PAGE UPDATED December 13, 2011
Interfering Substances
No inhibitory effects observed from interfering substances including hemoglobin, triglycerides, bilirubin, gamma-globulin, and SPS, introduced directly into blood and then cultured in the blood culture bottle. Multiple types of blood culture bottles were also tested.
Fresh vs. Frozen Samples
Test results for representative strains of MRSA/SA and MRSE/SE were unaffected by exposure to up to two freeze/thaw cycles.
Competitive Inhibition
Competitive inhibition representing mixed bacteremia with SA and SE was evaluated by testing SA/MRSA samples at a high titer in the presence of SE/MRSE at a low titer (at LOD) and vice versa. No evidence of competitive inhibition was observed.
Carry-over / Cross-contamination
No evidence of carryover and/or cross-contamination from the high positive samples, or any other internal or external sources, was observed during either the sample extraction and hybridization procedural steps, when alternately running high positive samples followed by true negative samples.
Performance Data - Clinical Testing
Precision and Reproducibility Studies
The Reproducibility Study was conducted at three external sites and the Precision Study took place internally at Nanosphere, Inc. The Precision and Reproducibility Study Panel comprised of twelve (12) specimens, consisting of pure isolates grown in blood culture bottles until bottle positivity and bottle positivity plus an additional 8 hours. The specimens included 2 levels of 2 different MRSA strains, 2 levels of a MRSE strain. 2 negative controls (1 media only and 1 bacterial), 2 levels of an SA strain, and 2 levels of an SE strain.
Each specimen was tested in duplicate twice daily by two operators for twelve days (precision) and five days (reproducibility). The study demonstrated excellent reproducibility across multiple reagent lots, days, operators, runs, instruments and replicates.
| Precision | Reproducibility | |||
|---|---|---|---|---|
| NS | Site 1 | Site 2 | Site 3 | All Sites |
| 100 % | ||||
| (576/576) | ||||
| 99.4 % - 100 % | 100 % | |||
| (240/240) | ||||
| 98.5 % - 100 % | 100 % | |||
| (240/240) | ||||
| 98.5 % - 100 % | 100 % | |||
| (240/240) | ||||
| 98.5 % - 100 % | 100 % | |||
| (1296 / 1296) | ||||
| 99.7 % - 100 % |
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Method Comparison
The Method Comparison Study was conducted at five external clinical sites. Subjects included individuals receiving routine care requiring blood culture testing. Three-hundred and thirty (330) culture-positive, gram-positive (GPCCL) blood culture specimens from these patients were identified for BC-S testing. BC-S test results were compared with reference method results obtained from the standard biochemical bacterial detection and susceptibility techniques utilized in routine clinical practice.
| S. aureus (n=330) | S. epidermidis (n=330) |
|---|---|
| Sensitivity =100% (97.1%-100%) | Sensitivity = 97.0% (91.2%-99.4%) |
| Specificity=100% (98.2%-100%). | Specificity= 99.6% (97.6%-99.9%) |
| mecA (n=221) | |
| Sensitivity =98.6% (94.6%-99.8%) |
Substantial Equivalence
Specificity= 98.8% (93.4%-99.9%)
The Verigene Staphylococcus Blood Culture Nucleic Acid Test (BC-S) is as safe and effective as the AdvanDx S. aureus/CNS PNA FISH Culture Identification Kit, Cepheid Xpert MRSA/SA Blood Culture Assay, BD Phoenix Gram Positive (GP) Panel - Phoenix Automated Microbiology System (Cefoxitin) and Nanosphere Verigene RVNAT sp. The BC-S has similar intended use and indications, technological characteristics, performance characteristics and principles of operation as its predicate devices. The minor differences between the BC-S and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the BC-S is as safe and effective as predicate devices. Thus, the BC-S is substantially equivalent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
Image /page/6/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the eagle. The eagle is depicted in black, and the text is also in black.
10903 New Hampshire Avenue Silver Spring, MD 20993
Nanosphere, Inc. c/o Mark A. Del Vecchio Vice President, Regulatory Affairs 4088 Commercial Avenue Northbrook, IL 60062
DEC 1 6 2011
Re: K112424
Trade/Device Name: Verigene® Staphylococcus Blood Culture Nucleic Acid Test (BC-S) on the Verigene® System Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: NQX, NSU Dated: December 13, 2011 Received: December 15, 2011
Dear Mr. Del Vecchio:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice
7
Page 2 - Mark A. Del Vecchio
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nallartagna
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
8
PAGE UPDATED December 13, 2011
4. Indications for Use Statement
510(k) Number (if known): K112424
Device Name: Verigene® Staphylococcus Blood Culture Nucleic Acid Test (BC-S) on the Verigene® System
The Verigene® Staphylococcus Blood Culture (BC-S) Nucleic Acid Test performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacterial species Staphylococcus aureus ("SA") and Staphylococcus epidermidis ("SE") which may cause bloodstream infection (BSI). In addition, the BC-S test detects the mecA resistance marker inferring mecA-mediated methicillin/oxacillin resistance. In mixed growth, the BC-S Test does not specifically attribute mecA-mediated methicillin/oxacillin resistance to either SA or SE.
The BC-S test is performed directly on positive blood culture using BACTEC "10 Plus Aerobic/F and BacT/ALERT FA FAN® Aerobic blood culture bottles, which contain gram-positive cocci in clusters (GPCCL) observed on Gram stain. Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing, differentiation of mixed growth, association of the mecA gene to an organism, or for epidemiological typing.
The BC-S test is indicated for use in conjunction with other clinical and laboratory findings, such as culture, to aid in the diagnosis of bacterial bloodstream infections; however, it is not used to monitor bloodstream infections.
Prescription Use (Part 21 CFR 801 Subpart D)
and/or
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Freddie te Poole
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Office of In Vitro Diagnostic Device Evaluation and Safety
FIG(k) K112424
Z:\REGULATORY\Submissions\B BC S Test 510(k) 08192011
CONFIDENTIAL AND PROPRIETARY Nanosphere, Inc.
Page 25 of 168
ATTACHMENT 3 Page 1 of 1